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Is there a greater opportunity for generic drugs in China?

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  In recent years, the industry has been calling for opportunities from the global generics wave, specifically at home, where exactly are the opportunities?

  At present, China's pharmaceutical industry consists of chemical drugs (including chemical apis and preparations), accounting for 45%. China is capable of producing more than 1,500 kinds of chemical API, with an output of 2 million tons. The annual output of over 10,000 tons is penicillin, amoxicillin, vitamin C and vitamin E. The production and export of more than 20 kinds of chemical apis represented by penicillin and vitamin C rank first in the world. Statins, primers and sartan have become new export advantages.

  China produces more than 4,000 kinds of chemical pharmaceutical preparations, which can basically meet the needs of the state for disease prevention and control. Chinese pharmaceutical companies now have a total of 187,000 drug approval codes, of which 121,000 are chemical approval codes and the vast majority are generic drugs.

  Current situation: the total profit of chemical pharmaceutical industry exceeds 100 billion yuan

  In 2014, China's pharmaceutical industry realized primary business revenue of 2.5 trillion yuan, up 13.1% year on year, and realized a total profit of 246 billion yuan, up 12.3% year on year. The value of export delivery reached 174.1 billion yuan, up 6.6 percent year on year.

  Among them, the main business income of the chemical and pharmaceutical industry was 1.1 trillion yuan, up 11.8% year on year. Total profits reached 104.6 billion yuan, up 14.9% year on year. The value of export delivery reached 75.2 billion yuan, up 2.5% year on year.

  In 2014, China approved 507 listed drugs, of which 466 were chemical drugs, accounting for 91.9%. Among the approved varieties of chemical drugs, 220 generic drugs, accounting for 47%, 127 new drugs, accounting for 27%. There are 63 imported drugs, accounting for 14%.

  It is worth noting that the total sales volume of the international API market in 2014 reached us $134 billion. In 2014, the total export value of China's API was 16 billion us dollars and the total import value was 8.5 billion us dollars.

  Pan guangcheng, executive vice President of the China chemical and pharmaceutical industry association, believes that "low dose and high effective price" will be the development direction of API in the future.

  On the other hand, in 2014, China's chemical pharmaceutical products export achieved rapid growth in several high-end markets.

  Relevant data show that in 2014, the Chinese chemical medicine preparations exports was $2.94 billion, up 8.4% from a year earlier, imported 12.78 billion us dollars, up 15.6% from a year earlier, the growth in exports to the United States is as high as 24%, of the association of south-east Asian nations (asean), Brazil and Russia's emerging market exports increased by 20%, 21.6% and 20% respectively; Exports to several central and east African countries grew by more than 40 per cent

  More than 50 Chinese pharmaceutical companies have passed the certification of Europe, America and Japan, 7 enterprises have passed the certification of WHO, and nearly 50 pharmaceutical products have obtained the American ANDA number.

  Opportunity: API market share increased to 55%

  At present, there are still many problems in the development of generic drugs in China.

  Pan Guangcheng points out, because our country medicine industry technical ability and production management level and lower level of awareness of generic drugs has also led to a generic medicine pharmaceutical basic research is weak; Studies on the source selection of raw and auxiliary materials, crystal shape control of raw materials, selection of prescription and process parameters and test stability are not enough.

  In addition, China's early approval standards for generic drugs were not strict enough, and some enterprises did not conduct comprehensive and in-depth comparative studies on generic drugs and original drugs. The quality of generic drugs is different from that of the original ones.

  However, China's generic drugs industry is facing an unprecedented period of opportunity as several "blockbuster" patents expire.

  In 2014-2020, seven years, there will be a $259 billion drug patents expire, which expects a 46% market share, one occupied by generics experts predict China generics market size is close to 500 billion yuan in 2015.

  At present, the world pharmaceutical market is only growing at a slow rate of 4-5% a year, but generic drugs are growing at an annual rate of 11%, becoming the leading sector for the sustainable development of the global pharmaceutical industry. The world's generic drugs market has grown from $89 billion in 2007 to $180 billion in 2014.

  Pan Guangcheng thinks, from the point of change trend, used for generic apis share expands unceasingly, this is good news for hospital API production country, API market share has risen from 45% in 2008 to 55% in 2014.

  China has more than 200 million people over the age of 60, and the aging population is accelerating. In the next 10-20 years, it will be difficult to meet the first-line clinical needs by independent innovation of drugs. In the future, generic drugs will still be the support and basic guarantee of China's medical and health system.

  So how do companies share a slice of the generic market in new opportunities?

  Pan guangcheng believes that a leapfrog development model should be established for the development, production and registration of generic drugs. The government should support enterprises to concentrate on copying expired patented drugs and export them to the European, American and Japanese markets, and establish green channels to improve the efficiency of approval of generic drugs. Promote the quality consistency evaluation of generic drugs and improve the quality of generic drugs. We will implement policies to support generic drugs and promote the sound development of the generic drugs industry.


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